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New hope for young cancer patients: glofitamab trial targets tough lymphoma

NCT ID NCT05533775

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 04, 2026 · Updated 6 times

Summary

This study tests a drug called glofitamab, which helps the immune system find and kill cancer cells, in children and young adults (ages 6 months to under 30) whose B-cell lymphoma has come back or not responded to treatment. Some participants receive glofitamab alone, while others get it combined with standard chemotherapy. The goal is to see if the drug is safe and can shrink or eliminate tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
glofitamab (a drug that helps the immune system attack cancer cells), given alone or with standard chemotherapy (rituximab, ifosfamide, carboplatin, etoposide)
What this could lead to
If successful, this could provide a new treatment option for children and young adults with hard-to-treat B-cell lymphoma, potentially improving remission rates.
What could go wrong
This is an early-phase trial (Phase 1/2) with only 65 participants, so results may not apply to everyone. Side effects from the drug or chemo could be serious, and the treatment may not work for all.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 65 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Nov 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months to 30 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 6 months to \< 18 years at the time of signing Informed Consent for Cohort A Part 1 and Cohort B of the study, and age 6 months to \< 30 years old at the time of signing Informed Consent for Cohort A Part 2 of the study * Histologically re-confirmed diagnosis, via tissue biopsy, or bone marrow aspirate, pleural effusion, or ascites, prior to study entry of aggressive mature B-NHL that expresses CD20 (reconfirmed by IHC or flow cytometry if IHC is not possible), including BL, BAL (mature B-cell leukemia FAB L3), DLBCL, and PMBCL, at the time of first R/R disease for Cohort A and second or greater R/R disease for Cohort B * Refractory or relapsed disease (i.e., prior treatment was ineffective or intolerable) following first-line standard-of-care chemoimmunotherapy for Cohort A and following at least two prior systemic chemoimmunotherapy regimens and who have exhausted all available established therapies for Cohort B * Measurable disease, defined as: At least one bi-dimensionally measurable nodal lesion, defined as \> 1.5 cm in its longest dimension, or at least one bi dimensionally measurable extranodal lesion, defined as \> 1.0 cm in its longest dimension; or percentage of bone marrow involvement with lymphoma cells defined by cytomorphological analysis of bone marrow aspirates * Adequate performance status, as assessed according to the Lansky or Karnofsky Performance Status scales: Participants \< 16 years old: Lansky Performance Status ≥ 50%; Participants ≥ 16 years old: Karnofsky Performance Status ≥ 50% * Adequate bone marrow, liver, and renal function * Negative test results for acute or chronic hepatitis B virus (HBV), hepatitis C virus (HCV) * Negative HIV test at screening, with the following exception: Individuals with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count ≥200/uL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months * Negative SARS-CoV-2 antigen or PCR test within 7 days prior to enrollment * Participants and/or caregivers who are willing and able to complete clinical outcome assessments throughout the study using either paper or interviewer methods Exclusion Criteria: * Isolated CNS disease of mature B-NHL without systemic involvement, and primary CNS lymphoma * Receipt of glofitamab prior to study enrollment * Ongoing adverse events from prior anti-cancer therapy that were not resolved to Grade ≤ 1 (exceptions: alopecia, Grade 2 peripheral neuropathy) * Grade ≥ 3 adverse events, with the exception of Grade 3 endocrinopathy managed with replacement therapy * Participants with active infections which are not resolved prior to Day 1 of Cycle 1 * Prior solid organ transplantation * Known or suspected history of hemophagocytic lymphohistiocytosis (HLH), or chronic active Epstein-Barr viral infection (CAEBV) * Active autoimmune disease requiring treatment * History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products, except if the participant was able to safely receive it after initial administration (consider consultation with Medical Monitor) * History of confirmed progressive multifocal leukoencephalopathy * Current or past history of uncontrolled non-malignant CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease * Evidence of significant and uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results * Major surgery or significant traumatic injury \< 28 days prior to the obinutuzumab pretreatment infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment * Administration of a live, attenuated vaccine within 4 weeks before the start of study treatment (obinutuzumab pretreatment) or at any time during the study treatment period and within 12 months after end of study treatment * Participants with any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug

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Conditions

The condition(s) this trial relates to.

B-cell non-Hodgkin lymphoma Burkitt lymphoma diffuse large B-cell lymphoma primary mediastinal large B-cell lymphoma Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mature B-cell non-Hodgkin lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    30 sites in 13 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Children's Hospital of Alabama

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • Childrens Mercy Hosp & Clinics

    RECRUITING

    Kansas City, Missouri, 64108, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Fakultni nemocnice v Motole;Klinika detske hematologie a onkologie

    RECRUITING

    Prague, 150 06, Czechia

  • Graacc-Grupo de Apoio ao adolescente e a crianca com cancer

    RECRUITING

    São Paulo, São Paulo, 04023-062, Brazil

  • Guangxi Cancer Hospital of Guangxi Medical University

    RECRUITING

    Nanning, 530201, China

  • Gustave Roussy

    RECRUITING

    Villejuif, 94800, France

  • Hospital Erasto Gaertner

    RECRUITING

    Curitiba, Paraná, 81520-060, Brazil

  • Hospital Infantil Universitario Niño Jesus

    RECRUITING

    Madrid, 28009, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hôpital Pellegrin

    RECRUITING

    Bordeaux, 33076, France

  • IRCCS Ospedale Pediatrico Bambino Gesù

    RECRUITING

    Rome, Lazio, 00165, Italy

  • Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21231, United States

  • Kaiser Permanente - Roseville

    RECRUITING

    Roseville, California, 95661, United States

  • Kaiser Permanente - Santa Clara

    RECRUITING

    Santa Clara, California, 95051, United States

  • Kaiser Permanente Oakland Medical Center

    RECRUITING

    Oakland, California, 94611, United States

  • MSKCC

    RECRUITING

    New York, New York, 10065, United States

  • Ospedaliera Ospedale Infantile Regina Margherita

    RECRUITING

    Turin, Piedmont, 10126, Italy

  • Perth Children's Hospital

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Ponadregionalne Centrum Onkologii Dzieci?cej ,,Przyladek Nadziei?;Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej we Wroclawiu

    RECRUITING

    Wroclaw, 50-556, Poland

  • Queensland Children?s Hospital

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

  • Rigshospitalet

    RECRUITING

    København Ø, 2100, Denmark

  • Semmelweis Egyetem II. sz. Gyermekgyogyaszati Klinika

    RECRUITING

    Budapest, 1097, Hungary

  • Seoul National University Hospital- Pediatric Site

    RECRUITING

    Seoul, 03080, South Korea

  • Sun Yet-sen University Cancer Center

    RECRUITING

    Guangzhou, 510060, China

  • UCSF Benioff Children's Hospital Oakland

    RECRUITING

    Oakland, California, 94609, United States

  • Universitaetsklinikum Muenster

    RECRUITING

    Münster, 48149, Germany

  • West China Second University Hospital

    RECRUITING

    Chengdu, 610041, China

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